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Trial Summary


Protocol No.EA4151/BMTCTN1601
StatusOPEN TO ACCRUAL
Principal InvestigatorRobertson, Michael
ScopeNational
PhasePhase III
Age GroupAdult
TitleA Randomized Phase III Trial of Consolidation with Autologous Hematopoietic Cell Transplantation Followed by Maintenance Rituximab vs. Maintenance Rituximab Alone for Patients with Mantle Cell Lymphoma In Minimal Residual Disease-Negative First Complete Remission
DescriptionThis randomized phase III trial studies rituximab after stem cell transplant and to see how well it works compared with rituximab alone in treating patients with in minimal residual disease-negative mantle cell lymphoma in first complete remission. Monoclonal antibodies, such as rituximab, may interfere with the ability of cancer cells to grow and spread. Giving chemotherapy before a stem cell transplant helps kill any cancer cells that are in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. After treatment, stem cells are collected from the patient's blood and stored. More chemotherapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. Giving rituximab with or without stem cell transplant may work better in treating patients with mantle cell lymphoma.
Key EligibilityIn order to be eligible to take part in this trial, patients must meet the following criteria:

  • Patients must have histologically confirmed mantle cell lymphoma, with documented cluster of differentiation (CD19) or CD20 expression and cyclin D1 (BCL1) by immunohistochemical stains and/or t(11;14) by cytogenetics or fluorescence in situ hybridization (FISH); the diagnosis must be confirmed by formal hematopathology review at the enrolling center, including assessment of Ki-67 proliferation index (=< 30% versus > 30% versus ?indeterminate? Ki-67 index)
  • Patients should be deemed to be potentially eligible and willing candidates for auto-HCT by the enrolling physician
For a full list of participation criteria, please visit clinicaltrials.gov.
Applicable Disease SitesNon-Hodgkin's Lymphoma
Participating InstitutionsIndiana University (IU)
    Treatment TypeTreatment
    ContactPhone: (317) 278-5632
    Email: iutrials@iu.edu